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Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer

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ClinicalTrials.gov Identifier: NCT01794312
Recruitment Status : Active, not recruiting
First Posted : February 18, 2013
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea

Brief Summary:
The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.

Condition or disease Intervention/treatment Phase
Keratitis Corneal Ulcer Device: T4020 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
Study Start Date : January 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: T4020
One drop 4 times per week
Device: T4020
Placebo Comparator: Vehicle
One drop 4 times per week
Device: T4020



Primary Outcome Measures :
  1. evaluation of the keratitis/ulcer area [ Time Frame: Day 28 ]
    Evaluation of the corneal healing at Day 28 with the keratitis/ulcer area measures from baseline


Secondary Outcome Measures :
  1. Number of adverse events recorded [ Time Frame: all visits ]
  2. Best corrected visual acuity [ Time Frame: Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients diagnosed with one chronic keratitis/corneal ulcer
  • Patients who signed and dated informed consent

Exclusion Criteria:

  • Patient under 18 years
  • Patient with a perforated corneal ulcer OR any risk of immediate perforation of corneal ulcer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794312


Locations
France
Medical Director
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
Laboratoires Thea

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01794312     History of Changes
Other Study ID Numbers: LT4020-PIII-12/11
First Posted: February 18, 2013    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Ulcer
Keratitis
Corneal Ulcer
Pathologic Processes
Corneal Diseases
Eye Diseases
Eye Infections
Infection